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Developmental Dyslexia and Remediation Methods (DDMR)

Primary Purpose

Dyslexia, Developmental

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phonological
Visual-attention
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dyslexia, Developmental

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 8 years old and ≤ at 13 years old;
  • Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests.
  • Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test.
  • Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests.
  • Home equipped with a connected computer system for daily training.
  • Signing of informed consent by the parents
  • The child must be affiliated to a social security scheme

Exclusion Criteria:

  • Intellectual retardation, neurological disorders, pervasive developmental disorder;
  • Primary sensory deficit;
  • Educational deficiencies;
  • attention deficit hyperactivity disorder, dysphasia;
  • Previous daily phonological or visual-attentional training.

Sites / Locations

  • Hôpitaux Pédiatriques de Nice CHU-Lenval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phonological group

visual-attention group

Arm Description

Outcomes

Primary Outcome Measures

reading skills effectiveness
measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation

Secondary Outcome Measures

reading skills effectiveness 8 weeks
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
reading skills effectiveness 18 weeks
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
orthographic skills effectiveness
count of orthographic (number of errors) in raw scores and standard deviation
reading comprehension skills effectiveness
measure of reading comprehension level (error rates) in raw scores and standard deviation
perception of the evolution of the reading disorder
measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13 Score from 5 to 1 For example, "I like to read" a lot = 5, a lot = 4, normal" = 3, a little = 2, not at all = 1 Another example "it's easy to read", really very easy = 5, I do well = 4, normal = 3, a little difficult = 4, very difficult = 1 The maximum value 5 means that reading and learning are perceived very positively The minimum value 1 means that reading and learning are perceived very negatively Results: An increase in scores measured before and after the three training sessions means an improvement

Full Information

First Posted
July 18, 2019
Last Updated
September 28, 2023
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT04028310
Brief Title
Developmental Dyslexia and Remediation Methods
Acronym
DDMR
Official Title
Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation
Detailed Description
Developmental dyslexia is defined as a specific and lasting reading learning disorder. This neurodevelopmental disorder has a severe impact on overall academic learning and behavior, compromises professional and social development and affects 10% of school-age children. As a public health problem, its diagnosis and management are still highly controversial, and the lack of scientific consensus leads to great heterogeneity in clinical practices and post-treatment outcomes. Three therapeutic axes guide research for developmental dyslexia. The first axis is based on phonological deficits. According to the phonological representation hypothesis, a specific deficit in the processing of phonological representations that support the identification of sounds is the cause of the reading disorder. The second axis focuses on attention-related cognitive deficits. According to the visuo-attention deficit hypothesis, a lack of the visuo-attention processing can be viewed as one of the explanatory causes of a dysfunction in letter identification and reading procedures. The third axis aims to achieve automatized processing for letter/sound association. According to the axis, a lack of cross-modal integration in word decoding is altered by a lack of simultaneous association between of a visual and an auditory stimulus. Many studies attempted to exclusively validate selective remediation according to causal hypotheses that are mainly cross-modal, phonological or visuo-attentional. However, the evaluation of these underlying processing in dyslexic children shows great clinical heterogeneity since most of children simultaneously have the three deficits. Furthermore, no study evaluates the benefits of combining these different trainings on reading skills. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation. The secondary objectives will be 1°) to compare the effectiveness on reading skills of a phonological training, versus a visuo-attentional training, 2°) to compare the effectiveness on reading skills from in the order of phonological and visuo-attentional training, 3°) to compare the evolution of performance in comprehension and written production at the end of the three training sessions and 4°) to evaluate child and parents' perception for the outcome of the reading disorder at the end of the training sessions using Likert scales, by means of a questionnaire. The analysis of the results will make possible to evaluate a remedial approach to dyslexia in a clinical context and to better understanding and management of written language disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia, Developmental

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phonological group
Arm Type
Experimental
Arm Title
visual-attention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Phonological
Intervention Description
Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks) Phase 2: intervention with targeted daily training Phonological training (15 minutes/ day, 5 days/week, for 8 weeks) Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks) Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks) Phase 3: stopping training sessions for 8 weeks
Intervention Type
Other
Intervention Name(s)
Visual-attention
Intervention Description
Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks) Phase 2: intervention with targeted daily training Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks) Phonological training (15 minutes/ day, 5 days/week, for 8 weeks) Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks) Phase 3: stopping training sessions for 8 weeks
Primary Outcome Measure Information:
Title
reading skills effectiveness
Description
measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation
Time Frame
26 weeks to baseline
Secondary Outcome Measure Information:
Title
reading skills effectiveness 8 weeks
Description
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
Time Frame
8 weeks to baseline
Title
reading skills effectiveness 18 weeks
Description
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
Time Frame
18 weeks to baseline
Title
orthographic skills effectiveness
Description
count of orthographic (number of errors) in raw scores and standard deviation
Time Frame
26 weeks to baseline
Title
reading comprehension skills effectiveness
Description
measure of reading comprehension level (error rates) in raw scores and standard deviation
Time Frame
26 weeks to baseline
Title
perception of the evolution of the reading disorder
Description
measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13 Score from 5 to 1 For example, "I like to read" a lot = 5, a lot = 4, normal" = 3, a little = 2, not at all = 1 Another example "it's easy to read", really very easy = 5, I do well = 4, normal = 3, a little difficult = 4, very difficult = 1 The maximum value 5 means that reading and learning are perceived very positively The minimum value 1 means that reading and learning are perceived very negatively Results: An increase in scores measured before and after the three training sessions means an improvement
Time Frame
26 weeks to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 8 years old and ≤ at 13 years old; Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests. Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test. Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests. Home equipped with a connected computer system for daily training. Signing of informed consent by the parents The child must be affiliated to a social security scheme Exclusion Criteria: Intellectual retardation, neurological disorders, pervasive developmental disorder; Primary sensory deficit; Educational deficiencies; attention deficit hyperactivity disorder, dysphasia; Previous daily phonological or visual-attentional training.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HARRAR-ESKINAZI KARINE
Organizational Affiliation
CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Pédiatriques de Nice CHU-Lenval
City
Nice
Country
France

12. IPD Sharing Statement

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Developmental Dyslexia and Remediation Methods

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